MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Catalog Number BXA082902J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 10/24/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Without a lot number or device serial number, the manufacturing date and/or production details cannot be determined, and the information provided to gore cannot be connected to a specific device.The device remains implanted and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.Further information for this procedure was requested by gore, however, no further information has been reported , therefore this investigation is considered complete.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following information was reported to gore: on (b)(6) 2022, the patient underwent endovascular treatment using a gore® viabahn® endoprosthesis with heparin bioactive surface.Jhjr080502j (serial unknown) was implanted for a repair of the superior mesenteric artery aneurysm with dissection.On (b)(6) 2022, since the celiac artery was identified to be a possible responsible artery for the aneurysm, this patient underwent endovascular treatment and jhjr080502j (serial unknown) was implanted in the celiac artery.During the procedure, a proximal type i endoleak was suspected, so an additional stent graft, a gore® viabahn® vbx balloon expandable endoprosthesis (bxa103901j/serial unknown) was placed in the proximal side.A distal type i endoleak was also suspected, and an additional stentgraft (bxa082902j/serial unknown) was placed in the distal side.The post-dilatation was performed by mustang balloons and the procedure was completed without any further endoleaks.On the same day, about 2 hours after the procedure, the patient vital signs decreased.Because bleeding from the splenic artery was confirmed, reintervention was performed.As a treatment, the splenic artery was coil embolized and an additional stent graft was placed distal side of bxa082902j.No comment was received from the physician about the cause of the splenic artery injury.

Manufacturer Narrative

B2 corrected to select for applicable outcomes for the reported serious injury.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kaitlin barnash ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15789761
• MDR Text Key: 303572895
• Report Number: 2017233-2022-03479
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BXA082902J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization